Update to Federal and State Controlled Substance Laws and - PowerPoint PPT Presentation

Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific Meeting February 22, 2020 Tyler Dougherty, PharmD Assistant Professor of Pharmacy Practice South College School of Pharmacy

Disclosure Information I have no financial relationships to disclose and I will not discuss off label use or investigational use in my presentation.

Objectives • Compare and contrast chronic pain guidelines and their applications • Discuss the role of co-prescribing naloxone in high risk patients • Review the Tennessee buprenorphine treatment guidelines and challenges with medication-assisted treatment (MAT) • Examine new and potential federal and state legislation affecting opioid prescribing • Utilize the Tennessee Controlled Substance Monitoring Database in practice

Outline CURRENT LANDSCAPE PRESCRIBING CSMD OPIOIDS NALOXONE MAT LEGISLATION

Current Landscape

National Landscape • 70,237 drug overdose deaths in 2017 • 47,600 overdose deaths related to opioids • 191,146,822 opioid prescriptions dispensed by retail pharmacies • >17,000 people die annually from prescription opioid overdose (46/day) • Largely remained unchanged • Heroin overdose death rates have largely remained unchanged • More than 28,000 deaths involving synthetic opioids in 2017 • Almost a 50% relative change from 2016 Scholl L, Seth P, Kariisa M, et al. Drug and Opioid-Involved overdose Deaths – United States, 2013-2017. MMWR. 67 (51 & 52): 1419-1427. https://www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm675152e1-H.pdf

National Landscape

TN Overdose Deaths 2000 1818 1776 1800 1631 1600 1451 Number of Deaths 1400 1263 1166 1094 1200 1000 800 600 400 200 0 2012 2013 2014 2015 2016 2017 2018 Year Tennessee Drug Overdose Dashboard. TN Department of Health. https://www.tn.gov/health/health-program-areas/pdo/pdo/data-dashboard.html

TN Landscape – 2018 Data • 1,818 total overdose deaths • 1,304 deaths attributed to opioids • Fentanyl deaths increased 70% • 43% of individuals who died from a drug overdose had a controlled substance dispensed within the last 60 days • Heroin deaths increased 20% • 44% of opioid-related overdose deaths included a benzodiazepine Controlled Substance Monitoring Database: 2019 Report to the 111 th Tennessee General Assembly. March 1, 2019. https://www.tn.gov/content/dam/tn/health/healthprofboards/csmd/2019%20Comprehensive%20CSMD%20Annual%20Report.pdf

TN Landscape • From 2012-2018, number of MME dispensed has decreased 43% • 2012-2018 number of opioid prescriptions for pain have decreased by 30% • 2012-2018 number of patients receiving >120 MME/day has decreased 48% • First year on record for decrease in NAS cases • Stimulant prescribing continues to increase • 51% growth from 2010-2018 Controlled Substance Monitoring Database: 2019 Report to the 111 th Tennessee General Assembly. March 1, 2019. https://www.tn.gov/content/dam/tn/health/healthprofboards/csmd/2019%20Comprehensive%20CSMD%20Annual%20Report.pdf

TN Landscape Controlled Substance Monitoring Database: 2019 Report to the 111 th Tennessee General Assembly. March 1, 2019. https://www.tn.gov/content/dam/tn/health/healthprofboards/csmd/2019%20Comprehensive%20CSMD%20Annual%20Report.pdf

TN Landscape Miller AM, McDonald M (2019). Neonatal Abstinence Syndrome Surveillance Annual Report 2018. Tennessee Department of Health, Nashville, TN. https://www.tn.gov/content/dam/tn/health/documents/nas/NAS%20Annual%20Report%202018%20FINAL.pdf

TN Landscape Controlled Substance Monitoring Database: 2019 Report to the 111 th Tennessee General Assembly. March 1, 2019. https://www.tn.gov/content/dam/tn/health/healthprofboards/csmd/2019%20Comprehensive%20CSMD%20Annual%20Re port.pdf

Chronic Pain Guidelines PRESCRIBING OPIO IOIDS DS

CDC Chronic Pain Guidelines • Assess risk factors prior to initiating opioids • Previous treatments • Co-morbidities • History (overdose, SUD) • CSMD • Can use a therapeutic trial of opioids • Requires informed consent and treatment agreement • Use the lowest effective dose • 50 MME/day • 90 MME/day CDC Checklist: https://www.cdc.gov/drugoverdose/pdf/pdo_checklist-a.pdf

CDC Chronic Pain Guidelines • Avoid benzodiazepines with opioid • Must use UDT at onset and at least annually • Check PDMP at onset and every three months • Follow up with patient: • Change of dose: 1-4 weeks • Stable dose: every 3 months • Acute pain: 3 days sufficient, 7 days rarely CDC Checklist: https://www.cdc.gov/drugoverdose/pdf/pdo_checklist-a.pdf

Limitations to CDC Guidelines

Limitations to CDC Guidelines • Inflexible application of recommended ceiling doses/durations as hard limits • Abrupt opioid taper or cessation • Limited coverage and access to multi-modal, comprehensive care • OUD diagnosis difficulty and access barriers • Payors applying dosage limits Kurt Kroenke, Daniel P Alford, Charles Argoff, Bernard Canlas, Edward Covington, Joseph W Frank, Karl J Haake, Steven Hanling, W Michael Hooten, Stefan G Kertesz, Richard L Kravitz, Erin E Krebs, Steven P Stanos, Mark Sullivan, Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline: A Consensus Panel Report, Pain Medicine , Volume 20, Issue 4, April 2019, Pages 724 – 735, https://doi.org/10.1093/pm/pny307

Petrosky E, Harpaz R, Fowler KA, et al. Chronic Pain Among Suicide Decedents, 2003 to 2014: Findings From the National Violent Death Reporting System. Ann Intern Med. [Epub ahead of print 11 September 2018]169:448 – 455. doi: 10.7326/M18-0830

Individualized, Integrative Treatment U.S. Department of Health and Human Services (2019, May). Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations. Retrieved from U. S. Department of Health and Human Services website: https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html

Tapering: Benefits vs Risk Dowell D, Compton WM, Giroir BP. Patient-Centered Reduction or Discontinuation of Long-term Opioid Analgesics: The HHS Guide for Clinicians. JAMA. Published online October 10, 2019. doi:10.1001/jama.2019.16409.

TN Chronic Pain Guidelines • Can use a therapeutic trial of opioids • Requires informed consent and treatment agreement • Use the lowest effective dose, immediate release products • Discuss and document the 5 A’s (analgesia, activities of daily living, adverse side effects, aberrant drug-taking behaviors and affects) at each visit Tennessee Chronic Pain Guidelines. https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf

TCA §63-1-164 “Informed consent”… at a minimum: A healthcare practitioner may treat a patient (i) Adequate information to allow the with more than a three-day supply of an patient or the patient's legal opioid if the healthcare practitioner treats the representative to understand: patient with no more than one (1) (a) The risks, effects, and characteristics prescription for an opioid per encounter of opioids, including the risks of physical and:(i) Personally conducts a thorough dependency and addiction, misuse, and evaluation of the patient; diversion; (ii) Documents consideration of non-opioid (b) What to expect when taking an and non-pharmacologic pain management opioid and how opioids should be used; strategies and why the strategies failed or and were not attempted; (c) Reasonable alternatives to opioids (iii) Includes the ICD-10 code for the primary for treating or managing the patient's disease in the patient's chart, and on the condition or symptoms and the benefits prescription when a prescription is issued; and and risks of the alternative treatments; (iv) Obtains informed consent and documents the reason for treating with an opioid in the chart. Acts 2018, ch. 1039, § 6; 2019, ch. 117, § 1; 2019, ch. 124, §§ 7-13.

Informed Consent Tennessee Chronic Pain Guidelines. https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf

TN Chronic Pain Guidelines • Primary Care Providers are encouraged to treat patients requiring <120 MME/day • If patient requires >120 MME/day, must consult with pain medicine specialist • If patient requires >120 MME/day for more than 6 months, must consult with a pain medicine specialist annually Tennessee Chronic Pain Guidelines. https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf

TN Chronic Pain Guidelines • Assess risk for abuse • ORT • SOAPP-R • Establish treatment goals • 3 item PEG Assessment Scale • Avoid benzodiazepines with opioid • Must use UDT at onset and at least twice yearly • Check CSMD at least twice yearly per law • Cannot use telemedicine Tennessee Chronic Pain Guidelines. https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf